Catalog Number

-

Brand Name

ENDOEYE FLEX 3D DEFLECTABLE VIDEOSCOPE

Version/Model Number

OLYMPUS LTF-190-10-3D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123365

Product Code

FGB

Product Code Name

Ureteroscope and accessories, flexible/rigid

Public Device Record Key

5a9d00d4-94ee-47b5-86fc-e31d942aaba7

Public Version Date

November 23, 2021

Public Version Number

4

DI Record Publish Date

September 21, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-